$885 – $4,912

Auditing Analytical Laboratories for FDA Compliance (ntz) A

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Manila

Manila, NCR

Philippines

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Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.


Who will benefit:

The following specific types of workers will benefit from this webinar:

  • External and Internal Auditors
  • Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups
  • Supervisors and Analysts in Contract Testing Laboratories
  • Personnel Responsible for Selecting Contract Testing Laboratories
  • Consultants

Day 1 Schedule


Lecture 1:

GMP Regulations that Apply to Analytical Laboratories


Lecture 2:

Reviewing Documentation


Lecture 3:

Advance Preparation for the Audit


Lecture 4:

Auditing Styles and Structures



Day 2 Schedule


Lecture 1:

Equipment and Laboratory Instrument Qualification


Lecture 2:

What to look for while doing a Walk-Through


Lecture 3:

Other Regulations and Standards, including ISO 17025


Lecture 4:

Following through on the Audit



Dr. Steven Kuwahara

Founder & Principal, GXP Biotechnology, LLC

Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS
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Date and Time

Location

Manila

Manila, NCR

Philippines

View Map

Refund Policy

No Refunds

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